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Terminated

V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufactured by Siemens Medical Solutions, Mountain View, CA. Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary or secondary ultrasound echo data. The V5Ms is a multi frequency, multiplane, phased sector array transducer. It can be introduced into the esophagus to obtain images of the heart structure.

FDA Recall Z-1392-2011 · Posted 2011-02-22

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeITX
Date Initiated2009-08-28
Date Terminated2011-03-29
Product Quantity97 units

Reason for Recall

If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.

Firm Action

Siemens sent a Customer Safety Advisory Notification letter on August 28, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their local Customer Service Engineer would install a software update as soon as it becomes available. Customers were instructed to pass the Customer Safety Advisory Notification letter to all who need to be aware of these issues until the corrective action is completed. For questions regarding this recall call 650-969-9112 or 800-422-8766.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Canada, China, Czech Republic, Denmark, Germany, Great Britian, Hong Kong, Indonesia, Italy, Japan, Norway, Poland, Portugal, Russian Federation, Singapore, South Korea, Taiwan, and Turkmenistan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc., Ultrasound DI · 2008-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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